AI-powered Early Detection for Pancreatic Cancer Via Non-contrast CT in Opportunistic Screening Cohort

NCT06638866 | Recruiting DMC

• 4 other identifiers: AI-PANC-120240106320244020820511101200
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 3

Brief Summary

Pancreatic ductal adenocarcinoma (PDAC) remains a therapeutic challenge with 5-year survival rates of 13%, primarily attributable to advanced-stage diagnosis (AJCC Stage III/IV in \>80% of cases). This prospective, observational, multi-center study will evaluate the performance of an AI-powered opportunistic screening system utilizing non-contrast computed tomography (NCCT) acquired during routine clinical encounters or health check-ups. The proposed AI model will perform automated detection of pancreatic parenchymal abnormalities, including PDAC and precursor lesions (intraductal papillary mucinous neoplasms \[IPMN\], mucinous cystic neoplasms \[MCN\]). Algorithm-positive cases will be independently reviewed by two radiologists. Highly suspected individuals will undergo further diagnostic verification, including serological tests and multimodal imaging confirmation. Patients with confirmed positive diagnosis will receive multidisciplinary consultation and specialized treatment, whereas those with negative results will undergo at least one-year clinical follow-up. This study will quantitatively evaluate the AI system's performance, and aims to advance PDAC early detection, improve patient outcomes, and make it accessible in underserved populations.

Conditions

Pancreatic Cancer; Pancreatic Ductal Adenocarcinoma; Pancreatic Intraepithelial Neoplasias; Intraductal Papillary Mucinous Neoplasm; Mucinous Cystic Neoplasm

Keywords

Early Screening; Early Diagnosis; Artificial Intelligence; Pancreatic Cancer; Pancreatic Lesion; PDAC; Non-contrast CT

Outcome Measures

Primary Outcomes (4)

• Detection rate of PDAC

  Defined as the proportion of histologically confirmed PDAC among all participants undergoing CT screening.

  3 years

• Detection rate of high-risk precursor lesions

  Defined as the proportion of histologically confirmed precursor lesions (IPMN/MCN) meeting Sendai criteria among all participants undergoing CT screening.

  3 years

• PPV

  Defined as the proportion of histologically confirmed PDAC and high-risk precursor lesions among all AI-positive screening cases.

  3 years

• Recall rate

  Defined as the proportion of individuals recalled for further validation via serological and imaging tests after AI-positive screening and radiologist review among all participants undergoing CT screening.

  3 years

Secondary Outcomes (2)

• Early-stage PDAC Proportion

  3 years

• Survival time

  5 years

Other Outcomes (1)

• Potential harms associated with screening procedures and treatments

  3 years

Study Arms (2)

AIgorithm-classified PDAC Group

Participants who underwent non-contrast abdominal and/or chest CT scans and were preliminarily classified by the aIgorithm as PDAC.

Diagnostic Test: PDAC

AIgorithm-classified Pancreatic Precursor Lesions Group

Participants who underwent non-contrast abdominal and/or chest CT scans and were preliminarily classified by the aIgorithm as pancreatic precursor lesions.

Diagnostic Test: Pancreatic precursor lesions

Interventions

PDAC DIAGNOSTIC_TEST

Participants with algorithm-identified PDAC will be independently reviewed by two radiologists. Those highly suspected will be recalled for further diagnostic evaluation, including serological tests (e.g., CA19-9, CEA) and imaging (e.g., contrast-enhanced CT/MRI, EUS-FNA). Participants with a confirmed positive diagnosis will undergo multidisciplinary consultation and specialized treatment, while those with a negative diagnosis will be followed clinically for at least one year.

AIgorithm-classified PDAC Group

Pancreatic precursor lesions DIAGNOSTIC_TEST

Participants with algorithm-identified pancreatic precursor lesions will be independently reviewed by two radiologists. Those highly suspected will be recalled for further diagnostic evaluation, including serological tests (e.g., CA19-9, CEA) and imaging (e.g., contrast-enhanced CT/MRI, EUS-FNA). Participants with a confirmed positive diagnosis will undergo multidisciplinary consultation and specialized treatment, while those with a negative diagnosis will be followed clinically for at least one year.

AIgorithm-classified Pancreatic Precursor Lesions Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population included adults aged 18 years or older undergoing routine non-contrast chest and/or abdominal CT scans for non-pancreatic indications, while exclusion criteria comprised a history of pancreatic cancer, thoracic or abdominal surgery, acute pancreatitis within the past 6 months, or referral for evaluation of suspected or confirmed pancreatic cancer.

You may qualify if:

• \. Individuals undergoing routine non-contrast chest and/or abdominal CT scans for non-pancreatic indications.

You may not qualify if:

• History of pancreatic cancer;
• History of thoracic or abdominal surgery;
• Acute pancreatitis within 6 months;
• Patients referred for evaluation of suspected or confirmed pancreatic cancer.

Sponsors & Collaborators

• Changhai Hospital: lead
• Yinzhou Hospital Affiliated to Medical School of Ningbo University: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator
• Central Hospital of Lishui City: collaborator
• Jingning County People's Hospital: collaborator
• Alibaba DAMO Academy: collaborator

Study Sites (3)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Second Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, 314000, China

RECRUITING

Yinzhou Hospital Affiliated to Medical School of Ningbo University

Ningbo, Zhejiang, 315100, China

RECRUITING

Related Publications (10)

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  PMID: 32593337 BACKGROUND

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  PMID: 32135127 BACKGROUND

• Young MR, Abrams N, Ghosh S, Rinaudo JAS, Marquez G, Srivastava S. Prediagnostic Image Data, Artificial Intelligence, and Pancreatic Cancer: A Tell-Tale Sign to Early Detection. Pancreas. 2020 Aug;49(7):882-886. doi: 10.1097/MPA.0000000000001603.

  PMID: 32675784 BACKGROUND

• Stoffel EM, Brand RE, Goggins M. Pancreatic Cancer: Changing Epidemiology and New Approaches to Risk Assessment, Early Detection, and Prevention. Gastroenterology. 2023 Apr;164(5):752-765. doi: 10.1053/j.gastro.2023.02.012. Epub 2023 Feb 18.

  PMID: 36804602 BACKGROUND

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• US Preventive Services Task Force; Owens DK, Davidson KW, Krist AH, Barry MJ, Cabana M, Caughey AB, Curry SJ, Doubeni CA, Epling JW Jr, Kubik M, Landefeld CS, Mangione CM, Pbert L, Silverstein M, Simon MA, Tseng CW, Wong JB. Screening for Pancreatic Cancer: US Preventive Services Task Force Reaffirmation Recommendation Statement. JAMA. 2019 Aug 6;322(5):438-444. doi: 10.1001/jama.2019.10232.

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  PMID: 37985692 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jin Gang, M.D.

  Changhai Hospital

  STUDY CHAIR

• Wang Bei Lei, M.D.

  Changhai Hospital

  STUDY DIRECTOR

Central Study Contacts

Wang Bei Lei, M.D.

CONTACT

86-13774238083; lilly_wang@126.com

Guo Shi Wei, M.D.

CONTACT

86-18621500666; gestwa@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: October 15, 2024
• Study Start: August 3, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)